Safety of percutaneous aortic valve insertion. A systematic review

<p>Abstract</p> <p>Background</p> <p>The technique of percutaneous aortic valve implantation (PAVI) for the treatment of severe aortic stenosis (AS) has been introduced in 2002. Since then, many thousands such devices have worldwide been implanted in patients at high risk for conventional surgery. The procedure related mortality associated with PAVI as reported in published case series is substantial, although the intervention has never been formally compared with standard surgery. The objective of this study was to assess the safety of PAVI, and to compare it with published data reporting the risk associated with conventional aortic valve replacement in high-risk subjects.</p> <p>Methods</p> <p>Studies published in peer reviewed journals and presented at international meetings were searched in major medical databases. Further data were obtained from dedicated websites and through contacts with manufacturers. The following data were extracted: patient characteristics, success rate of valve insertion, operative risk status, early and late all-cause mortality.</p> <p>Results</p> <p>The first PAVI has been performed in 2002. Because of procedural complexity, the original transvenous approach from 2004 on has been replaced by the transarterial and transapical routes. Data originating from nearly 2700 non-transvenous PAVIs were identified. In order to reduce the impact of technical refinements and the procedural learning curve, procedure related safety data from series starting recruitment in April 2007 or later (n = 1975) were focused on. One-month mortality rates range from 6.4 to 7.4% in transfemoral (TF) and 11.6 to 18.6% in transapical (TA) series. Observational data from surgical series in patients with a comparable predicted operative risk, indicate mortality rates that are similar to those in TF PAVI but substantially lower than in TA PAVI. From all identified PAVI series, 6-month mortality rates, reflecting both procedural risk and mortality related to underlying co-morbidities, range from 10.0-25.0% in TF and 26.1-42.8% in TA series. It is not known what the survival of these patients would have been, had they been treated medically or by conventional surgery.</p> <p>Conclusion</p> <p>Safety issues and short-term survival represent a major drawback for the implementation of PAVI, especially for the TA approach. Results from an ongoing randomised controlled trial (RCT) should be awaited before further using this technique in routine clinical practice. In the meantime, both for safety concerns and for ethical reasons, patients should only be subjected to PAVI within the boundaries of such an RCT.</p

Prognosis of perioperative myocardial infarction after off-pump coronary artery bypass surgery

Aim. Perioperative myocardial infarction (PMI) is associated with long-term morbidity and mortality. CKMB cut-off level and importance of Q-wave MI have not been specifically studied after off-pump coronary artery bypass (OPCAB) surgery. The aim of this paper was to study the impact of PMI (CKMB ≥20 times the upper normal limit [UNL] 100 μg/L) and CKMB rise (5-20 UNL) on survival and recurrent major adverse cardiac event (MACE) after OPCAB surgery. Methods. One thousand consecutive prospectively followed OPCAB patients operated between September 1996 and March 2004 were analyzed. Follow-up was complete in 97% of the cohort. Average follow-up was 66±28 months. Results. Overall and cardiac survival at 10 years was 70±2.6% and 88+2.3%, respectively. Evolving MI (EMI) occurred in 1.8%, postoperative non-Q MI (NQMI) in 1.3%, and Q-wave MI (QMI) in 2.0%. Operative mortality was higher in PMI patients (P20 UNL) was a strong predictor of operative mortality. QMI and EMI were predictors of long-term mortality and cardiac morbidity after OPCAB surgery. CKMB 10-20 UNL affected long-term cardiac survival but not overall survival.SCOPUS: ar.jinfo:eu-repo/semantics/publishe

Percutaneous fixation of tibial plateau fractures under arthroscopy: a medium term perspective.

ERMAInternational audienceINTRODUCTION: Arthroscopically assisted percutaneous internal fixation has found its place in the treatment of Schatzker I-III tibial plateau fractures, with good short-term results reported. The objective of this study was to observe the progression of osteoarthritis at the medium term through clinical and radiological assessment. PATIENTS AND METHODS: Twenty-seven patients were treated with arthroscopy-assisted percutaneous fixation for stage I-III Schatzker tibial plateau fractures. RESULTS: Twenty-one patients were reviewed with a mean follow-up of 59.5 months (range, 24-138 months); satisfaction was good except for return to sports activity. The mean IKS score was 85.2 for the knee score and 91 for function. The mean Lysholm score was 86 points, with a mean Tegner activity score of 4. A mean score of 25.5 and 8 points was found for the clinical and radiological Rasmussen scores, respectively; 47.6% of the patients presented early osteoarthritis on radiological evaluation. DISCUSSION: The medium-term functional results were comparable to the short-term results. The patients were satisfied except for return to sports activity. Age at surgery appears as a prognostic factor for osteoarthritis. CONCLUSION: Arthroscopic internal fixation remains the technical reference for Schatzker I-III tibial plateau fractures despite the appearance of osteoarthritis, which remains less extensive than in open surgery. LEVEL OF EVIDENCE: Level IV. Retrospective study

Surgical aspects of endovascular retrograde implantation of the aortic CoreValve bioprosthesis in high-risk older patients with severe symptomatic aortic stenosis

ObjectivesAortic stenosis is one of the most common forms of acquired valvular heart disease in adults, and the proportion of patients unsuitable for conventional surgery is increasing. Consequently, the development of new less-invasive techniques to treat severe aortic stenosis is crucially important. Current experience in percutaneous aortic valve replacement is limited to a few groups, and the search for an optimal technique continues. We report our experience with retrograde endovascular bioprosthesis implantation with brief cardiopulmonary bypass support in high-risk older patients.MethodsThe CoreValve pericardial bioprosthesis (CoreValve, Inc, Paris, France) is sutured on a nitinol frame and delivered in a 21F catheter. All procedures were performed under femoro–femoral cardiopulmonary bypass support consisting of an aortic balloon valvuloplasty followed by prosthesis deployment within the aortic annulus under fluoroscopy. Ten high-risk surgical patients underwent percutaneous valve replacement.ResultsImmediate improvement in aortic valve function was observed in all patients. The aortic valve area increased from 0.57 ± 0.19 to 1.2 ± 0.35 cm2 (P = .00001), the mean transaortic valve gradient decreased from 51 ± 19 to 11 ± 3 mm Hg (P < .001). The 30-day mortality was 20%: one patient died 5 days after the procedure of a massive ischemic stroke and 1 patient died at 20 days of a hemorrhagic stroke. The median New York Heart Association functional class improved from III to II (P = .01).ConclusionsAortic valve replacement with the CoreValve bioprosthesis can be performed with favorable early technical results in high-risk patients. However, the morbidity and short-term mortality of such procedures remain significant

Complications with catheter-assisted aortic valve replacement after a transfemoral approach

Hintergund Seit mehr als 10 Jahren wird der kathetergestützte Aortenklappenersatz (Transkatheter-Aortenklappenimplantation, „transcatheter aortic valve implantation“, TAVI) durchgeführt. Bereits in der Anfangsphase haben sich eingriffstypische Komplikationen nach transfemoralem Zugang herauskristallisiert. Ziel der Arbeit Beispielhaft wird anhand von 4 Sektionsfällen beschrieben, wie die Indikationsstellung zur TAVI und die Vermeidbarkeit der Komplikation zu prüfen ist. Material und Methoden Bei einer 86-jährigen Frau war es im Rahmen eines Repositionsversuchs des Implantats zu einem Abriss der rechten Beckengefäße gekommen. Bei einer 82-jährigen Frau war es während der Intervention zu einem Einriss des Aortenklappenrings mit Perikardtamponade gekommen. Eine 89-jährige Frau erlitt während der Intervention eine gedeckte Aortenverletzung und war während der anschließenden operativen Versorgung des Defekts verstorben. Im vierten Fall war bei einer 83 Jahre alt gewordenen Patientin im Rahmen des transfemoralen Klappenersatzes die Positionierung der Klappe misslungen, und ventrikelwärts entwickelte sich eine Embolisation der entfalteten Klappe. Es wurde eine zweite gleichartige Klappe positioniert, die in der Aorta hielt. Ergebnisse Die Indikationsstellung zur TAVI war in den 4 Fällen der multimorbiden Patientinnen gerechtfertigt. Die Komplikationen waren sehr unterschiedlich und die Gefäßverletzungen in 2 Fällen aufgrund der begonnenen Operationen nicht mehr zu prüfen. Schlussfolgerungen Die Versorgung einer Komplikation ist beim indikationsgerechten Patientenkollektiv aufgrund der Multimorbidität extrem schwierig und mit zahlreichen weiteren Komplikationen behaftet. Schlüsselwörter Herzklappenerkrankungen – Herzklappenprothese – Minimalinvasive Verfahren – Behandlungsfehler – InoperabilitätBackground Catheter-assisted aortic valve replacement or transcatheter aortic valve implantation (TAVI) has been carried out for over 10 years. Even in the initial phases typical complications after a transfemoral approach became apparent. Aim This article describes how the indications for TAVI and the avoidance of complications must be checked as exemplified by four autopsy cases. Material and methods In the first case the iliac vessels in an 86-year-old female patient ruptured during an attempt to reposition the implanted valve. In the second case a laceration of the aorta occurred close to the original aortic valve and the 82-year-old female patient died due to pericardial tamponade. In the third case an 89-year-old woman suffered a covered laceration of the aorta and the patient died during an attempt to replace the vessel. In a further case of an 83-year-old woman during transfemoral valve replacement the positioning of the valve was unsuccessful and a second valve had to be implanted due to embolization of the unfolded valve. Results In all four cases the indications for TAVI in the multimorbid patients were justified. The complications were very different and in two cases assessment of the original vascular lacerations could no longer be carried out due the fact that surgery had already begun. Conclusion Most patients undergoing TAVI are multimorbid hence the treatment of complications becomes extremely difficult and bears a great risk of causing further complications